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The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome

NCT04416620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-06-04

No results posted yet for this study

Summary

The primary aim of this study was to estimate the prevalence of anxiety disorder and depression amongst Syrian and Jordanian women who are suffering from PCOS in Damascus and Amman.

The secondary aim was to assess the effectiveness of a PCOS pharmaceutical care service on selected patient's biochemical parameters, QOL, anxiety, and depression scale. The third aim is to identify the factors associated with QOL, anxiety and depression scores' change across the study.

Null Hypothesis (research hypothesis):

The intervention of PCOS pharmaceutical care service will lead to no significant differences in patient's depression, anxiety, QOL, and some biochemical parameters in comparison to females who will not receive this intervention in both Syria and Jordan.

Alternative Hypothesis (research hypothesis):

The intervention of PCOS pharmaceutical care service will have a significant impact on patient's depression, anxiety, QOL, and some biochemical parameters in comparison to patients who will not receive this intervention in both Syria and Jordan.

Conditions

  • Polycystic Ovary Syndrome

Interventions

OTHER

The PCOS pharmaceutical care service

The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym. The 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day. The 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition. The 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long-term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects.

Sponsors & Collaborators

  • Applied Science Private University

    lead OTHER

Principal Investigators

  • Iman A Basheti, Phd · ASU

  • Kinda T Alkoudsi, Master's · ASU

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-03-01
Completion
2017-07-30

Countries

  • Jordan
  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04416620 on ClinicalTrials.gov